Is There Time?
Meeting the ISO 9001:2000 transition deadline will be a challenge for some organizations
by John E. "Jack" West
The Dec. 15 deadline is fast approaching for organizations registered to the 1994 versions of ISO 9001, 9002 and 9003 to make the transition to ISO 9001:2000.
It seems as if we were finalizing the 2000 version for publication just a short while ago. But 27 months have gone by, and by the time you read this only about nine months will be left of the three-year transition period.
I am frequently asked if there is time to make the transition and get a registration upgraded to the new standard. My answer is always something like, "Well, that depends." Several factors influence the amount of time needed. Let's explore two:
- Whether a sector specific standard is being used.
- The maturity of the quality management system (QMS).
These issues may limit the ability of the registration system to get all organizations upgraded by the deadline. But I also expect some organizations will simply decide not to continue to hold certificates.
Some organizations in markets with no real demand for registration may believe they have already derived all the value they can from being registered. Others likely will be unwilling to make the commitment or meet some of the changes in requirements. Indeed, it is my opinion that some such fallout is desirable and could ultimately improve the credibility of the system.
Impact of Changes
While I will not discuss specific changes here, it will be useful to review the impact the changes are having on organizations. This impact depends largely on the nature and focus of an organization's current QMS.
As Figure 1 illustrates, the impact may be very slight for organizations with mature systems focused on customers and continual improvement and driven by top management. It is quite a different story for organizations that are internally focused or have uninvolved top management. This group may find the changes daunting and their effect profound.
Sector Specific Standards
Some organizations are in industries with a document that adopts ISO 9001 and adds industry specific explanations or requirements. For example, many companies in the automotive industry are registered to QS-9000 and will ultimately make the transition to ISO/TS 16949:2002. Others are registered to TL 9000 for the telecommunications industry or AS9100 for aviation and aerospace.
Most such organizations have been registered to both ISO 9001:1994 and the sector specific document. The sector specific standard may have a later deadline than that for ISO 9001 itself.
Many of these organizations view the deadline as that established within their own sector or may elect to limit their registration to only the sector document, foregoing or at least postponing certification to ISO 9001:2000. In addition, many organizations in sectors with their own standards have had to adopt fairly mature, customer focused QMSs to meet earlier versions of their industry's requirements.
Many organizations have mature QMSs that fully (or almost fully) comply with ISO 9001:2000. There has been a tendency for some to wait until their certificate is near expiration and upgrade at that time. While this is not a bad thing in itself, it is having a tendency to push a lot of registrar auditing into the last half of this year.
Organizations that are in this category absolutely need to get their upgrade audits scheduled with their registrar or they will face a seemingly inevitable capacity problem.
But that is not the real problem. While most organizations in this category will be able to make the transition on time, those that wait until the last minute may have missed an ideal opportunity to make a good QMS even better. Waiting to make the transition normally means missing opportunities and gaining little benefit.
Other organizations not really ready for the new requirements may well not have enough time to make needed changes in the overall focus of their QMSs. It is not the changes made to detailed requirements that may defeat such an organization's efforts, but rather the changes in overall focus needed.
Table 1 provides insight into these changes in focus. Let's look at four of the difficult issues such organizations with immature QMSs face:
1. Continual improvement.
2. Customer focus.
3. Top management's role.
4. Processes vs. procedures.
1. Continual improvement. While some of the people involved in writing ISO 9001:1994 say they intended for improvement to be an integral part of the requirements, most of us never really saw it that way.
Some organizations have spent time, money and effort to keep their real improvement activities completely separate from their formal QMSs. Sometimes this has been because improving quality was assigned to a different group in the organization. Sometimes it even has been because the goals of those responsible for control conflicted with the goals of those responsible for improvement. To fully comply with ISO 9001:2000, organizations must resolve these matters, and that takes time.
Then there is the matter of the relationship of improvement to the setting of real measurable quality objectives. Organizations with immature systems often have not yet made the effort to determine how to effectively measure their results. Organizations in this situation will need to start small by developing a set of quality objectives that align closely with their business objectives.
2. Customer focus. An internally focused organization needs to learn to focus on its customers. It can be argued that the only real additional customer related requirement in ISO 9001:2000 is measurement of customer satisfaction. But actually ISO 9001:2000 mentions customers much more often than did the 1994 standard, and it mentions customer satisfaction seven times.
3. Top management's role. I expect auditors for registrars will be spending a bit more time with top managers to determine whether they are really carrying out all the activities required of them in ISO 9001:2000. They will need to be more fully engaged in making decisions related to the QMS than ever before. It is time for quality professionals to quickly learn how to lead their bosses.
4. Processes vs. procedures. Then there is the little matter of the shift from ISO 9001:1994's procedure based system to ISO 9001:2000's process based one.
Much has been written in Quality Progress about ISO 9001:2000's process approach to QMSs,1 so I will not describe what it takes to use the approach. But it is the most important part of the standard to get right.
While ISO 9001:2000 has streamlined documentation requirements, it has significantly increased the emphasis on having a system made up of well-understood and interrelated processes. Each process needs to be managed and measured. Their interactions also need to be understood and managed to make the overall system effective.
Documentation of the system should be thought of as one way to ensure processes are operated in a controlled manner. But documentation is only one of the needed controls. You must also monitor and, where appropriate, measure the processes.
If you find yourself behind the time curve on the transition, you really need to carefully think through how you will address the shift in focus so you not only comply with the new standard but also gain the benefits it is intended to bring to your organization.
JOHN E. "JACK" WEST is a management consultant in the areas of productivity and quality. He served on the board of examiners for the Malcolm Baldrige National Quality Award and is now chair of the U.S. Technical Advisory Group to ISO Technical Committee 176 and lead delegate to the International Organization for Standardization committee responsible for the ISO 9000 family of quality management standards. He is co-author of ISO 9001:2000 Explained, published by ASQ Quality Press.